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GHENT, Belgium - Ablynx [Euronext Brussels: ABLX] today announced positive Phase I data from the single ascending dose part of the Phase I/II study with ALX-0061, the anti-IL-6R Nanobody, in patients with rheumatoid arthritis (RA). Based on these positive interim data, Ablynx has initiated a multiple ascending dose Phase II study with ALX-0061 in patients with RA.

During the period April to September 2011, the Phase I study recruited a total of 28 RA patients who received either placebo or a single dose of ALX-0061, injected intravenously. The single doses ranged from 0.3 mg/kg to 6 mg/kg. The study treatment was safe and well tolerated, and the biological effective doses were achieved at the doses established in the pre-clinical studies. The dose-dependent changes of the assessed biomarkers of early inflammation (C-reactive protein, fibrinogen and platelets) were consistent with the inhibition of the IL-6 pathway.

Following this study, three doses were selected for the Phase II study, including 1 mg/kg every 4 weeks, 3 mg/kg every 4 weeks, and 6 mg/kg every 8 weeks. This proof-of-concept Phase II study, which has been initiated today, is expected to recruit 36 RA patients. A first read out, including efficacy measures (DAS, ACR scores) is anticipated after 12 weeks and a final read out, including biomarker responses, is planned after 24 weeks.

Dr Edwin Moses, CEO and Chairman at Ablynx, commented:

"The rapid progress and the positive results from this first part of the Phase I/II study with ALX-0061 in RA patients gave us confidence to progress our IL-6R programme into the multiple ascending dose part of this study. We are on track to potentially achieve clinical proof-of-concept by the end of 2012."

He added:

"Now together with the rights to the anti-TNF-alpha Nanobodies which we have recently recovered, we believe we have an increasingly strong portfolio in inflammation, which includes a number of clinical assets with various modes of action that have the potential to address the complexity of RA and other autoimmune diseases, as not all patients adequately respond to current drugs."

About ALX-0061 (anti-IL-6R)

ALX-0061 is a Nanobody binding to the interleukin-6 receptor (IL-6R). It has the potential to be differentiated from the benchmark monoclonal antibody through its high potency, high stability and low molecular weight of only 26kD which could translate into superior tissue penetration, attractive PK/PD and a superior safety and efficacy profile. The Nanobody is half-life extended with a Nanobody targeting albumin, which is believed to improve the delivery of the Nanobody to inflamed tissues.

The involvement of the IL-6 pathway in a variety of diseases indicates that multiple indications can be pursued with large market potential including rheumatoid arthritis (RA), Crohn's disease, Castleman's disease, multiple myeloma and systemic lupus erythematosus (SLE).